Paragraph 14 Plant Protection Products (Fees and Charges) Regulations 2011

(1)

Schedule 1 is amended as follows.

(2)

In paragraph 1—

(a)

in the table—

(i)

in item 4 in the second column, after “application⁽²⁾” omit “⁽³⁾”;

(ii)

omit items 5, 5a and 5b;

(iii)

in item 11 in the second column, for “for lead zonal re-registration and new product applications” substitute “to discuss potential product applications”;

(iv)

omit item 12;

(b)

in the notes following the table—

(i)

omit notes (3), (5) and (6);

(ii)

in note (7) for “items 1-5, 10, 11 and 12” substitute “items 1-4, 10 and 11”;

(iii)

in note (16) omit “to the United Kingdom to act as lead zonal rapporteur”;

(iv)

omit note (17);

(v)

in note (18) for “the United Kingdom” substitute “a United Kingdom competent authority”.

(3)

In paragraph 2—

(a)

in the heading, for “or synergist” substitute “, synergist or basic substance”;

(b)

in the first sentence, for “or synergist” substitute “, synergist or basic substance”;

(c)

in the table—

(i)

in the heading before item 1, for “or synergist” substitute “, synergist or basic substance”;

(ii)

omit item 2;

(iii)

in item 3 for the words in the second column substitute “Co-ordination of scientific advice and public consultation and finalising the draft assessment report”;

(iv)

in items 7 and 10, for the words in the second column substitute “Co-ordination of scientific advice and public consultation, and finalising the draft assessment report”;

(v)

in item 12, in the second column, after “synergist,” insert “basic substance,”;

(d)

in the notes following the table—

(i)

omit note (2);

(ii)

in note (3)—

(aa)

at the beginning insert “In relation to active substances, safeners or synergists,”;

(bb)

after the first sentence insert “In relation to basic substances, a full data package comprises the complete dossier (the information referred to in Article 23(3) of Regulation 1107/2009) to support one or more uses of the basic substance.”;

(cc)

in the second sentence after “the product” insert “or basic substance”;

(iii)

in note (4)—

(aa)

omit paragraph (c);

(bb)

in paragraph (d) at the beginning insert “in relation to active substances, safeners or synergists,”;

(cc)

omit paragraph (e);

(dd)

in paragraphs (f) and (g), at the beginning insert “in relation to active substances, safeners or synergists,”;

(ee)

after paragraph (g) insert—

“(h)
in relation to basic substances, resubmissions (for example where the previous application for approval under Regulation 1107/2009 has been unsuccessful and a new application is made in an attempt to address all the concerns raised from that earlier submission);

(i)
in relation to basic substances, data to support a change to the conditions of approval of the basic substance.”;

(iv)

for the final sentence substitute—

“The evaluation of scientific peer reviewed open literature on the active substance or basic substance and its relevant metabolites will be treated as a partial data package.”

(4)

Omit paragraph 4 (including the table, and the notes following the table, in that paragraph).